2013 Electronic Working Group (e-WG) on the General Standard for Food Additives (GSFA)

Second Circular

1. The 45th Session of the Codex Committee on Food Additives (CCFA) agreed to establish an e-WG to develop:1

i) recommendations for the entry in the GSFA on proposals for new provisions in food category 16.0 (Prepared foods); ii) recommendations for the entry in the GSFA of new proposals and revision of existing provisions, contained in CX/FA 13/45/12 and in FA 45/CRDs 6 and 12, except for those provisions in food category 14.2.3 (Grape wines) and its sub-categories, and those provisions for (INS 951) and aspartame-acesulfame salts (INS 962); iii) proposals for the provisions in Table 1 and 2 of the GSFA of Table 3 food additives with “acidity regulator” function, which were held at the 45th Session, for their use for technological function other than as acidity regulators; and iv) Proposals for consideration of the provisions in Table 1 and 2 of Table 3 food additives with functions other than “emulsifier, thickener, stabilizer,” “colour,” and “sweetener”.

Points i) and ii): Proposals on New Provisions for Inclusion in, and Revision of Existing Provisions of, the GSFA

Background:

2. The 44th CCFA forwarded a revised title and descriptor for food category 16.0 to the Codex Alimentarius Commission for adoption at Step 8.2 As a result of this revision, the Committee also recommended revocation or discontinuation of all provisions currently in food category 16.0.3 The 44th CCFA also issued a Circular Letter (CL 2012/5-FA, Part B, point 9) requesting proposals for new provisions for the use of food additives in this food category in order to populate food category 16.0 with provisions appropriate to the revised title and descriptor.4

3. The 44th CCFA issued a Circular Letter (CL 2012/5-FA, Part B, point 10) requesting proposals for new or revised provisions for the GSFA to be submitted according to the Procedure for Consideration of the Entry and Review of Food Additive Provisions in the General Standard for Food Additives.5

4. Due to time constraints, the 45th CCFA was unable to discuss the proposals for new provisions for inclusion in food category 16.0 nor the proposals for new additive provisions and revisions of existing provisions of the GSFA. As a result, the Committee agreed to request that the e-WG on the GSFA prepare recommendations for the entry of the new provisions and revision of the existing provisions of the GSFA.6

Working Document

5. The second circular for proposals on new provisions for and revision of existing provisions of the GSFA is presented in two parts. Part I contains proposals for new provisions for inclusion in the GSFA at Step 2, submitted in response to CL 2012/5-FA, Part B, points 9 and 10, as well as comments on those proposals.7 Part II contains proposals for revision or revocation of existing provisions in the GSFA,

1 REP 12/FA para. 103. 2 REP 12/FA para. 114 and Appendix X. 3 REP 12/FA para. 114 and Appendix VII and VII. 4 REP 12/FA, para. 115. 5 REP 12/FA, para. 87. 6 REP 12/FA, para. 100. 7 CX/FA 13/45/11, CX/FA 13/45/12, FA/45 CRD 6, and FA/45 CRD 12.

submitted in response to CL 2012/5-FA, Part B, point 10.8 Both parts are presented in the format of Table 1 of the GSFA (the information is presented alphabetically by food additive name).

6. When compiling the comments to the first circular it was noted that many comments to part I focused on specific criteria in Section 3.2 of the Preamble to the GSFA, rather than general criteria for inclusion of a draft provision into the GSFA at Step 2. As per the Procedures for consideration of entry and review of food additive provisions in the General Standard for Food Additives (GSFA),9 the appropriate step to submit comments on the specific criteria in Section 3.2 is when a proposed draft provision is circulated for comment at Step 3. As such, the recommendations presented in part I are not based on a consensus approach to the comments submitted in response to the first circular. Rather, these recommendations are based upon whether the provision meets the minimum requirements for the inclusion of a food additive provision in the GSFA: 1) an evaluation by the Joint FAO/WHO Expert Committee on Food Additives; 2) inclusion in the International Numbering System (INS); and 3) that the comments to the first circular indicate that the additive is used in international trade (i.e. use of the additive in the food category by several Codex Members).

7. The draft recommendations in part II of the second circular are based upon a consensus approach which takes into account comments submitted by the current e-WG in response to the first circular.

Request for Comments

8. For Part I of the working document, the e-WG is invited to comment on the inclusion of the new provisions in the GSFA at Step 2. These comments will be used by the physical working group (p-WG) on the GSFA to the 46th CCFA to formulate a recommendation to the Committee for inclusion into the GSFA at Step 2. Should the Committee agree with a recommendation for inclusion in the GSFA at Step 2, the provision will be maintained in the GSFA at Step 2 and circulated for full comment at Step 3 at a future date as the Committee’s agenda permits. Should the Committee agree that insufficient information was provided to support inclusion of the provision into the GSFA at Step 2, the Committee will stop work on the proposed provision.

9. For Part II of the working document, the e-WG is invited to comment on the proposed revision or revocation of an existing provision currently in the Step process of the GSFA. These comments will be used by the p-WG to the 46th CCFA to formulate a recommendation to the Committee for inclusion in an Annex that will be maintained until such time that the Committee circulates the recommendation on the existing provision for comment. Should the Committee agree with inclusion of the recommendation in an Annex, the recommendation for revision or revocation will be maintained for consideration until the Committee circulates the provision for comment at a later date. Should the Committee agree that not enough information has been provided to support maintaining the proposal for revision or revocation, the Committee will stop work on the proposal.

10. When responding to Parts I and II, please do so by adding your comments to the provided Word document, rather than as separate documents. Space has been designated in the working documents for e- WG members to provide comment. Please utilize the designated fields so that all responses will be organized in a similar manner. If more space is needed for your comment, please summarize your comment in the designated field and provide further detail as an attachment. This will allow ease of collation for the final draft. Please include all members of the e-WG on your e-mail transmitting your comments.

Points iii) and iv): Proposals for the Provisions in Table 1 and 2 of the GSFA of Table 3 Food Additives for their Use for Technological Function other than “acidity regulator”, “emulsifier, thickener, stabilizer,” “colour,” and “sweetener”.

Background

8 CX/FA 13/45/12, FA/45 CRD 6, and FA/45 CRD 12. 9 Codex Procedural Manual, 21st Ed. (2013), Section II: Elaboration of Codex Standards and Related Texts, p. 55.

11. The p-WG on the GSFA for the 45th CCFA reached consensus on the horizontal approach for the use of Table 3 additives with “acidity regulator” function in food categories listed in the Annex to Table 3 of the GSFA.10 This p-WG then considered proposals for provisions for Table 3 additives with acidity regulator function in the context of this horizontal approach and recommended that when acidity regulators are not justified in a food category, provisions for Table 3 food additives with functions in addition to acidity regulator should be held at their current step in the GSFA.11

12. The 45th CCFA agreed that the e-WG on the GSFA for the 46th CCFA should prepare proposals for provisions for Table 3 food additives with functions in addition to acidity regulator for their use for technological function other than as acidity regulators.1 The 45th CCFA also tasked this e-WG to prepare proposals on the remaining provisions in Tables 1 and 2 of the GSFA for Table 3 additives, with the exception of those with the technological function “emulsifier, thickener, stabilizer” (which will be discussed by the p-WG for the 46th CCFA), and those with the technological function “colour” and “sweetener” (which will be affected by the discussion of the eWG on Note 161).1

Working Documents

13. The second circular for the provisions in Table 1 and 2 of the GSFA for Table 3 food additives for their use for technological function other than “acidity regulator”, “emulsifier, thickener, stabilizer”, “colour”, and “sweetener” is presented in the format of the food categories listed in the Annex to Table 3. The hierarchical nature of the food category system is reflected by including subcategories affected by the listing of a parent food category in the Annex. Information on corresponding Codex commodity standards and the use of food additives in those commodity standards is provided for each food category.

14. The second circular presents proposals for each provision (adopt, adopt with revision, discontinue, discontinue and move to subcategories as appropriate). These proposals are based upon a consensus approach taking into account alignment with corresponding Codex commodity standards and comments on the first circular proposals by members of the e-WG. These recommendations are based on a “weight of evidence” approach; that is, comments containing justifications were given more weight than comments with no supporting justification.

a) Consideration of provisions for specific additives with “emulsifier, thickener, stabilizer” function: The e-WG on the GSFA for the 45th CCFA prepared recommendations for provisions in Tables 1 and 2 for food additives listed in Table 3 with “emulsifier, stabilizer, thickener” function.12 The e- WG only considered provisions for those additives listed in Appendix X of Rep 11/FA. Due to time constraints, the p-WG on the GSFA for the 45th CCFA and the Committee were unable to discuss all of these recommendations. Therefore, the Committee agreed to request that p-WG on the GSFA for the 46th CCFA consider the remaining recommendations.13 During compilation of the first circular for the current e-WG it was noted that provisions for several Table 3 additives with “emulsifier, stabilizer, thickener” function were not considered by the e-WG on the GSFA for the 45th CCFA as those additives were not listed in Appendix X of Rep 11/FA. b) Consideration of provisions for specific additives for use as acidity regulators The 45th CCFA reached decisions on the majority of provisions for the use of Table 3 additives as acidity regulators.14 However, during compilation of the first circular for the current e-WG it was determined that several provisions for specific additives for use as acidity regulators were either not considered by the 45th Session of the CCFA, or the decision of the 45th CCFA was not consistent with existing Codex commodity standards. Recommendations for these provisions for the use of the additive as an acidity regulator have been compiled in the Appendix document to the second circular. Specifically:

10 FA45/CRD 2 Appendix IV. 11 FA 45/CRD 2, Appendix VI. 12 CX/FA 13/45/7. 13 REP 13/FA, para. 85 14 REP 13/FA, paras. 69 – 74.

-Subcategories of Food Category 09.2 (Processed fish and fish products, including mollusks, crustaceans, and echinoderms): The 45th CCFA reached consensus that, although the use of acidity regulators was not generally justified in food category 09.2, the use of acidity regulators in several of its subcategories is generally justified.10 Due to the hierarchical nature of the food category system, the 45th CCFA then considered whether provisions for additives with acidity regulator function only from food category 09.2 should be adopted in the corresponding subcategories to food category 09.2 where acidity regulators were justified. The 45th CCFA also held provisions in food category 09.2 for additives with functional effects in addition to acidity regulator for consideration of these additional functional effects in the parent food category (09.2). As such, the use of these additives as acidity regulators in the corresponding subcategories to food category 09.2 was not considered by the 45th CCFA. Should the current e-WG determine that these additives with functional effects in addition to acidity regulator are not used for these additional function effects in either food category 09.2 or its subcategories, the use of these food additives as acidity regulators in the subcategories of food category 09.2 would still need to be considered. Recommendations for the use of these additives as acidity regulators in the subcategories of food category 09.2 have been compiled in the Appendix document to the second circular; -Omission of Citric (INS 330) and Lactic acid, L-, D-, and DL- (INS 270) from Food Categories 13.1.1 (Infant formulae) and 13.1.3 (Formulae for special medical purposes for infants): The e-WG on the GSFA for the 45th CCFA noted that both and lactic acid are listed in the corresponding Codex commodity standards for food categories 13.1.1 and 13.1.3 and recommended that the provisions for these additives in those food categories currently in the Step process be forwarded for adoption at Step 8. However, these provisions were inadvertently omitted from the report of the p-WG and the 45th CCFA.15 As such these provisions remain in the Step process of the GSFA. Both the second circular and the Appendix document to the second circular contains recommendations that these provisions be forwarded for adoption at Step 8. - Error of comparison of Food Category 13.2 (Complementary foods for infants and young children) with corresponding Codex commodity standards (provisions for Sodium lactate (INS 325) and Tricalcium citrate (INS 333(iii)): The p-WG on the GSFA to the 45th CCFA attempted to align the provisions for acidity regulators in food category 13.2 with the corresponding commodity standards.16 The 45th CCFA agreed with this alignment proposal, including the discontinuation of food additive provisions for sodium lactate and tricalcium citrate in food category 13.2.17 During the compilation of this first circular it was noted that provisions for sodium lactate and tricalcium citrate are, in-fact, included in one of the commodity standards corresponding to food category 13.2. As such these provisions are included in the Appendix document to the second circular with a recommendation that they be adopted at Step 8 in the GSFA in accordance with the corresponding Codex commodity standard.

15. The following conventions were used to prepare the working documents:

- Subcategories not listed in the Annex to Table 3, but affected by the listing of the parent food category in the Annex to Table 3 are indicated by underlining the food category number of the affected subcategory. - When the recommendation is that a food additive provision be moved from a parent food category to a subcategory, the original provision in the parent food category will be indicated with strikethrough font and the new provision in the subcategory will be in bolded font with no Step indicated in the "Step/Adopted" column

15 FA 45/CRD 2, Appendix I, Part B. 16 REP 13/FA para. 72. 17 REP 13/FA paras. 73-74.

- Provisions for additives with “emulsifier, thickener, stabilizer” function are coded green. - Provisions for additives with “acidity regulator” function where the initial recommendation (for the use of the additive as an acidity regulator) refers to the Appendix document are coded red. - In the Appendix document, those provisions for sodium lactate and tricalcium citrate that are being reintroduced and are not in the Step process in the GSFA are indicated with underlined and bolded font with no Step indicated in the "Step/Adopted" column. - Comments by eWG members on the first circular proposal are recorded in red font.

Request for Comments

16. The e-WG is invited to comment on the initial proposals presented in this second circular. Please provide comment and justification even if you agree with the initial proposal. Please keep the following in mind when providing comment: - All comments should adhere to the Procedures for consideration of entry and review of food additive provisions in the General Standard for Food Additives (GSFA)9, in particular, in providing technological justification. Section 3.2 of the Preamble to the GSFA establishes the criteria for justifying the use of a food additive. Comments containing only a recommendation of adopt or discontinuation with no justification will be given low priority. - Please respond by adding your comments to the Excel spreadsheets, rather than as separate documents. Space has been designated in the working documents for e-WG members to provide comment. Please utilize the designated fields so that all responses will be organized in a similar manner. If more space is needed for your comment, please summarize your comment in the designated field and provide further detail as an attachment. This will allow ease of collation for the final draft. - For several provisions the Second Circular requests that specific information be provided for further discussion by the eWG. These requests are highlighted in bolded blue font. Please note that all eWG members are invited to comment on all of the recommended proposals presented in the current circular, not only the requests for information highlighted in blue font.

- Please include all members of the e-WG on your e-mail transmitting your comments.